Veru is moving forward with plans for a Phase III trial of its experimental weight loss drug enobosarm. The drug, a selective androgen receptor modulator (SARM), aims to help people with obesity lose fat while preserving muscle. It is being tested in combination with the GLP-1 receptor agonist Wegovy (semaglutide) from Novo Nordisk.
On Wednesday, Veru released new safety data from its Phase IIb trial, called QUALITY. The company said the combination of enobosarm and Wegovy led to fewer gastrointestinal (GI) side effects compared to Wegovy alone. These results have encouraged Veru to start designing its next clinical trial.
The QUALITY study enrolled 56 patients aged 60 or older into each of three groups. Participants received either 3 mg or 6 mg of enobosarm or a placebo, all combined with Wegovy. In January, Veru reported that patients taking enobosarm with Wegovy lost 71% less lean muscle and 27% more fat than those taking Wegovy and a placebo.
Despite these findings, experts were initially cautious. Some pointed out that Veru had not shared enough detail about the drug’s safety profile.
“People will be very cautious about any safety concerns,” said Dr. Daniel Drucker, an endocrinologist at the Lunenfeld-Tanenbaum Research Institute in Toronto. “The last thing you want is to solve one problem and create another.”
The new data from the QUALITY trial may help ease those concerns. Veru reported that enobosarm appeared to reduce GI side effects. Among those taking Wegovy and a placebo, 32 patients experienced GI issues such as nausea, diarrhea, reflux, constipation, and vomiting. In comparison, only 18 cases were reported in the group taking 3 mg of enobosarm with Wegovy.
Following these results, Veru has asked the U.S. Food and Drug Administration (FDA) for an end-of-Phase II meeting, expected next quarter, to plan the Phase III trial.
The upcoming study will be similar to QUALITY, with patients receiving enobosarm alongside a GLP-1 drug. However, the main goal of the Phase III trial will be to measure improvement in physical function using a stair climb test after 24 weeks. In the Phase II trial, the main goal was to measure the percentage change in total lean body mass after 112 days.
Secondary goals in the Phase III trial will include changes in lean mass, fat mass, insulin resistance, and HbA1c levels over 24 weeks.
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